Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.

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Detailed Description

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Conditions

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Skin and Soft Tissue Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vanco once daily

Subject receives vancomycin 30 mg/kg dose

Group Type EXPERIMENTAL

vancomycin

Intervention Type DRUG

vancomycin 30 mg/kg intravenous administered once daily

Vanco twice daily

Subject receives vancomycin 15 mg/kg twice daily

Group Type ACTIVE_COMPARATOR

vancomycin

Intervention Type DRUG

vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)

Interventions

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vancomycin

vancomycin 30 mg/kg intravenous administered once daily

Intervention Type DRUG

vancomycin

vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19 to 70 years
* Weight 40 - 80 kg
* Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated
* Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician
* Subject able to provide informed consent

Exclusion Criteria

* Known history of allergy to vancomycin
* Pregnancy
* Granulocytopenia (\< 1x109/L)
* Renal impairment (serum creatinine \> 177 µmol/L or eGFR \< 50 mL/min)
* Known history of vestibular disease or hearing loss
* Subjects treated with vancomycin within the previous month
* Subjects who have received more than 24 hours of vancomycin
* Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No